Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use

Summary

This study aims to evaluate the influence of genetic polymorphisms of OCTN1 and OCT2 and
other possible covariates on the kinetic disposition of GAB in patients undergoing GAB
chronic treatment. Thus, patients treated with GAB, for at least one week, are being
investigated.

Description

Gabapentin (GAB), an anticonvulsant used for the treatment of epilepsy and chronic pain, has
nonlinear kinetics, it is not metabolized and it is mainly eliminated by renal excretion.
Studies suggest that the renal excretion of GAB is dependent on active secretion by organic
cation transporter 2 (OCT2) and organic cation/ergothioneine transporter 1 (OCTN1). These
transporters are expressed at the membrane of the renal proximal tubules and they are
involved in the elimination of endogenous compounds and many drugs. The genetic polymorphism
of drug transporters has been studied to explain the kinetic disposition variability of
their substrates. The objective of this study is to investigate the influence of genetic
polymorphisms of OCTN1 and OCT2 and other possible covariates (e.g., sex, age, creatinine
clearance, body mass index) on the kinetic disposition of GAB in patients undergoing GAB
chronic treatment. Patients treated with GAB, for at least one week, are being investigated.
Blood and urine samples are being collected to GAB pharmacokinetic analysis, serum
creatinine analysis and for genotyping. The plasma concentration of GAB will be assessed
using liquid chromatography with UV detection (LC-UV).

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Medical and Biotech [MESH] Definitions

Petrosal Sinus Sampling

Sampling of blood levels of the adrenocorticotropic hormone (ACTH) by withdrawal of blood from the inferior petrosal sinus. The inferior petrosal sinus arises from the cavernous sinus and runs to the internal jugular vein. Sampling of blood at this level is a valuable tool in the differential diagnosis of Cushing disease, Cushing syndrome, and other adrenocortical diseases.

Lot Quality Assurance Sampling

A sampling methodology using small sample sizes when conducting surveys in small geographical or population-based areas or lots.

Chorionic Villi Sampling

A method for diagnosis of fetal diseases by sampling the cells of the placental chorionic villi for DNA analysis, presence of bacteria, concentration of metabolites, etc. The advantage over amniocentesis is that the procedure can be carried out in the first trimester.

Poisson Distribution

A distribution function used to describe the occurrence of rare events or to describe the sampling distribution of isolated counts in a continuum of time or space.

Sampling Studies

Studies in which a number of subjects are selected from all subjects in a defined population. Conclusions based on sample results may be attributed only to the population sampled.

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